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# Clinical Trial Enhancements Discussed in PDUFA Meetings
- URL: https://www.fdaweb.com/clinical-trial-enhancements-discussed-in-pdufa-meetings/
- Published: 2016-01-06T12:00:00.000Z
- Updated: 2026-09-15T02:25:28.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5134350

> PDUFA 6 reauthorization negotiators in the regulatory decision tools subgroup discussed innovative clinical trial design and model-informed drug development (MIDD) at their 11/18/15 meeting. Meeting [minutes](http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM478534.pdf?ref=fdaweb.com) say that agency and industry subgroups members continued discussion of proposed enhancements intended to advance simulation approaches that can support innovation and regulatory evaluation of novel complex clinical trial designs and clarify for sponsors FDA expectations for simulations needed to adequately characterize the performance of the complex trials.  
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> “FDA and industry discussed the approaches proposed by both parties that included public workshops, guidance development, and development of internal FDA Manuals of Policy and Procedures or standard operating policies and procedures,” the minutes say.  
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> The agency suggested conducting a pilot program for highly innovative trial designs for which simulations are necessary to determine trial operating characteristics. The pilot would include a limited number of IND applications and would involve dedicated meetings with the sponsor to discuss FDA expectations and review of simulations.  
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> Also discussed were proposed enhancements specific to the development and application of pharmaco-statistical models derived from preclinical and clinical data sources, which FDA is calling model-informed drug development approaches. Agency staff said that such approaches can be used to inform regulatory decision-making such as patient selection in clinical trials, individualized dosing for specific populations, or the need for post-marketing studies. FDA said that the concept and proposals related to MIDD were incorporated into industry’s proposal on innovative clinical trial designs, but suggested that the areas of modeling and simulation be considered separately from the simulation approaches used to determine operating characteristics for complex clinical trials that were discussed in the innovative clinical trial design proposal.